Extrait

Background and study aims This study would like to find out if a non-deceptive non-concealed placebo patch (that is a patch that contains no active ingredients) will help people reduce the number of cigarettes that they smoke. A placebo is something that looks like a real medical treatment, but isn’t. It could be a pill for example, or another type of “fake” treatment. Placebos do not contain any active substances that have been developed to improve health. Researchers often use placebos to help them understand the effects of a new treatment (by comparing the effects on participants taking the new drug with those taking the placebo). However, some people do respond to a placebo. This Is referred to the placebo effect and there are some cases where it happens even when a person knows that they are taking a placebo. It is seen as a possible explanation for why some patients have a greater chance of a good outcome when given a dummy pill rather than being given nothing at all. It is also a possible explanation of why some patients still believe in treatments that are known not to work or are not clinically proven. This could be due to belief or the powers of suggestion, which might be a very important aspect of a treatment. This study looks at whether given a patch known to be a placebo to smokers helps them to reduce the number of cigarettes that they smoke. Who can participate? Adults that have smoked for at least 2 years and want to stop smoking. What does the study involve? All participants are told before starting the study that the best way to stop smoking (and therefore reduce their dependence on nicotine) is to reduce the number of cigarettes that they smoke over time. Participants are randomly allocated to one of two groups. Those in group 1 (the placebo patch group) are given a 56 day supply of placebo smoking cessation patches. They are all told that the patches are placebos and are monitored for 56 days to see whether they reduce the number of cigarettes that they smoke. Those in group 2 (control group) are not given any patches but are also monitored for 56 days to see whether they reduce the number of cigarettes that they smoke. What are the possible benefits and risks of participating? It is possible that participating in this study will help in reducing the number of cigarettes that a person smokes. The main risk to participating is nicotine withdrawal symptoms. Where is the study run from? University of Santo Tomas (Philippines) When is the study starting and how long is it expected to run for? January 2015 to October 2015 Who is funding the study? Investigator initiated and funded (Philippines) Who is the main contact? Mr Kevyn Yu

Critère d'inclusion

• Smoking addiction

Liens

• isrctn
• ictrp